Kornimate/medical-research-clean huggingface dataset:
anti-inflammatory and anti-thrombotic therapy with colchicine and low dose rivaroxaban for major adverse cardiovascular events reduction in ischemic stroke

Conditions: Ischemic Stroke

Summary: the archimedes study (anti-inflammatory and anti-thrombotic therapy with colchicine and low dose rivaroxaban for major adverse cardiovascular events reduction in ischemic stroke) will be a randomized, double-blind, 2x2 factorial clinical trial, which will include at least 3000 and up to a maximum of 4500 patients with ischemic stroke without indication of oral anticoagulation.

in patients with ischemic stroke, within 14 days of symptom onset, to establish the efficacy and safety of two strategies in parallel: low-dose rivaroxaban and low-dose colchicine, compared with placebo.

Eligibility criteria:
inclusion criteria: * patients with acute ischemic stroke aged ≥18 years old who, regardless of etiology and mechanism, do not have a definitive indication for anticoagulation, and whose symptoms onset has been within the last 14 days; * receiving standard therapy for acute management of ischemic stroke; * for patients treated with fibrinolytics, a minimum period of 24 hours after the infusion of the lytic drug is required for randomization into the study. exclusion criteria: * modified rankin score of 4 or more at randomization; * refusal to provide consent; * severe renal failure, with glomerular filtration rate (by ckd-epi) estimated at \<15 ml/min/1.73 m2; * severe liver failure (child c); * indication for full-dose anticoagulation (for example, venous thromboembolism or atrial fibrillation); * previous hemorrhagic stroke or history of intracranial hemorrhage; * systemic treatment with a potent cyp 3a4 inhibitor (such as azole antifungals and protease inhibitors), or with a potent 3a4 inducer (such as rifampicin, phenytoin, phenobarbital, or carbamazepine); * history of inflammatory bowel disease or chronic diarrhea; * prolonged treatment (\> 1 month) with immunosuppressants or systemic corticosteroids; * history of recurrent pneumonia (3 or more hospitalizations in the last 12 months); * pregnancy or breastfeeding; * any other comorbidity other than stroke and cv disease (e.g., metastatic cancer) that, in the investigator's opinion, has a significant impact on the 12-month survival.

Keywords: stroke anticoagulation rivaroxaban colchicine
clinical performance of the diassess influenza a and b test

Conditions: Influenza, Human; Influenza; Flu

Summary: the primary objective of this study is device feasibility of the diassess influenza a and b test


Eligibility criteria:
inclusion criteria: * subject currently has a fever (≥37.8°c/100°f), or self-reports having had or is currently treating a fever ≥37.8°c/100°f with onset within the previous 72 hrs * subject has at least one additional flu-like symptom including fever or feeling feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired), sore throat, headaches, or cough exclusion criteria: * subject received nasal vaccine (e.g. flumist) within the past 10 days * subject has been taking or took any antivirals for influenza in the past 30 days * subject enrolled in any drug trials
irofulven in treating patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: phase ii trial to study the effectiveness of irofulven in treating patients who have metastatic breast cancer. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

objectives: i. evaluate the response rate and time to treatment failure in patients with refractory metastatic adenocarcinoma of the breast treated with irofulven. ii. assess the qualitative and quantitative toxic effects of this drug in these patients. iii. determine the population pharmacokinetics and the pharmacokinetics-pharmacodynamic relationships of this drug in these patients. outline: this is a multicenter study. patients receive irofulven iv over 30 minutes on days 1 and 15. treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic adenocarcinoma of the breast * measurable disease outside previously irradiated area or occurred/progressed after completion of radiotherapy * must have received 1 or 2 prior chemotherapy regimens for metastatic disease * more than 3 prior regimens allowed * no active brain metastases or meningeal breast cancer involvement patient characteristics: sex: * male or female performance status: * swog 0-2 hematopoietic: * wbc at least 3,000/mm\^3 * platelet count at least 100,000/mm\^3 * absolute neutrophil count at least 1,500/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot or sgpt no greater than 3 times uln (5 times uln for liver metastases) renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance at least 60 ml/min cardiovascular: * no history of myocardial infarction or unstable angina within the past 6 months * no uncontrolled congestive heart failure other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * prior diagnosis of cancer allowed (must be off cancer therapy and have no evidence of disease) * no history of retinopathy and/or macular degeneration prior concurrent therapy: chemotherapy: * no prior irofulven

Keywords: stage iv breast cancer recurrent breast cancer male breast cancer
exploration of possible reasons for the discrepancy between expectation and indication of subjective perceived exertions

Conditions: Coronary Disease; Exercise Test; Physical Exertion; Cardiac Rehabilitation; Physical Therapy

Summary: the 6-minute walk test is a test of physical performance in physiotherapy with lungs and heart patients (pollentier 2010). however, only 8 and 11% of patients in everyday test situations report a score of 7 or higher on a scale of 0-10 for effort (jehn 2009). this study is intended to explore, based on grounded theory, why the majority of patients do not assess themselves according to the almost maximum performance.


Eligibility criteria:
inclusion criteria: * patients with coronary artery disease undergoing in-patient cardiovascular rehabilitation; over 55 years of age. patients underwent a 6-minute walk test with assessment of the intensity of the exercise exclusion criteria: * no understanding of the german language * patients would not be able to perform a 6-minute walk test, e. g. surgery on the large joints of the lower extremities, unstable heart disease or predominant neurological symptoms.
longitudinal follow-up of male soccer players prone to developing cam hip deformity

Conditions: Femoro Acetabular Impingement; CAM

Summary: femoroacetabular impingement (fai) is a clinical problem in which abnormal contact occurs between the thighbone and the hip socket. in intensive, mostly still young, male athletes, this problem seems to be related to a bony deformity on the head of this thighbone, a so-called cam. fai itself gives rise to pain symptoms, but in time can even lead to premature osteoarthritis. however, the cause of a cam deformity itself, nor how fai then arises, is insufficiently known. in view of fai prevention and its better treatment, this project thus tries to better understand the underlying mechanisms. for this purpose, we will combine detailed biomechanical evaluations of specific movement patterns with advanced medical imaging and state of the art clinical evaluations to longitudinally follow up a group with a known high risk of developing a cam deformity, being young male elite soccer players. findings within this study will be additionally compared with similar analyses performed in patients with fai. this research aims to thus form a basis to define novel (sports-specific) training schemes for the prevention of fai, but also to define the actual treatment and rehabilitation plans in more patient-specific and a better-informed way.

this is a longitudinal follow-up study in which subjects are invited for data collection twice, the baseline time-point and the two years time-point. population: 12-16 years old male soccer players (40 elite level players , and 40 recreational level players) in both data collection time-points the following measurements are preformed: 1. clinical screening of hip joint 2. radial mri of bilateral hips 3. biplanar and conventional x-ray imaging of hip and pelvic region 4. athlete-specific 3d motion analysis 5. questionnaires on injury history and physical activity levels.

Eligibility criteria:
inclusion criteria: * for the the elite group: playing soccer at high level and training for more that 10 hours a week * for the control group: playing soccer or any other sport recreationally for a less than 5 hours a week exclusion criteria: * no prior history of major trauma or injury to the lower limbs and spine * no prior history of neurological conditions that can effect movement and mobility
the importance of wnt-signaling after cardiac surgery

Conditions: Inflammation; Thoracic Surgery

Summary: cardiac surgery saves lives when patients suffer from cardiac disease. local inflammation is important for tissue repair and wound healing after such an operation. inflammation starts already when the patient is treated in the intensive care unit. when inflammatory proteins (cytokines) are released into the circulation, they cause also a systemic inflammation, which alerts the immune system of the body and activates defence mechanisms (=adaptive response). in some patients, systemic inflammation is out of control thereby causing organ dysfunctions, shock, and in the most severe cases even death (=maladaptive response). the aim of this study is to investigate the early phase of inflammation after the operation. repeated blood samples will be taken of patients undergoing cardiac surgery to describe the patterns and dynamics of inflammation proteins. a better understanding of these mechanisms will potentially lead to improved treatment of patients after cardiac surgery.

the aim of this project is to understand early inflammation mechanisms after cardiac surgery. therefore, repeated blood samples of patients undergoing cardiac surgery will be taken. patients are selected after "open" cardiac surgery (via sternotomy), when when they require postoperative care in the cardiovascular intensive care unit. the blood samples will be analysed in collaboration with the inflammation research unit of the department of internal medicine at the university hospital zurich.

Eligibility criteria:
inclusion criteria: * cardiac surgery via sternotomy * coronary-bypass bypass surgery with or without valve surgery * postoperative hospitalisation in the cardio-surgical icu * available informed consent exclusion criteria: * preoperative infections (e.g. endocarditis) * preoperative use of steroids or other immunosuppression

Keywords: cardia surgery cardio-pulmonary bypass inflammation wnt cytokines
glp-1 infusion and long-time fasting

Conditions: Type 2 Diabetes

Summary: glp-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion in a glucose dependent way. below normal plasma glucose levels the effects of glp-1 stop and the risk of hypoglycemia is small. however no results exits on the effects pharmacologically relevant doses of glp-1 during long-time fasting. there seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. the risk of hypoglycemia when glp-1 is administered will be evaluated during these two conditions.

glp-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion dependent on a normal plasma glucose.it also inhibits gastric emptying and has a trophic effect on the pancreatic beta-cells. below normal plasma glucose levels the effects of glp-1 stop and the risk of hypoglycemia is small.the counter regulatory response to hypoglycemia has been shown to be preserved during glp-1 infusion. however no results exits on the effects pharmacologically relevant doses of glp-1 during long-time fasting. there seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. the risk of hypoglycemia when glp-1 is administered will be evaluated during these two(48 hours of fasting followed by a glucose-load)conditions in healthy men. also the effect on 24 hour blood pressure will be evaluated.

Eligibility criteria:
inclusion criteria: * healthy male, age 20-50 years, bmi 20-30 kg/m2, blood pressure \< 140/90 mmhg, caucasian. exclusion criteria: * diabetes in relatives, anaemia, any significant disease, smoking.

Keywords: glp-1 fasting hypoglycaemia
coronary revascularisation by repot

Conditions: Coronary Disease

Summary: the presence of a coronary bifurcation complicates percutaneous revascularization. bifurcation stenting needs to take into account the difference of diameter between proximal and distal vessels and the necessity to limit the side branch obstruction. provisional stenting techniques with balloon juxtaposition as kissing balloon inflation (kbi) fail to demonstrate a clinical benefits. this is probably explain by the detrimental effect during these technics on the proximal segment with an arterial overstretch. a new sequential technique, named repot, demonstrated experimentally a mechanical superiority compared to juxtaposition balloon techniques included kbi. repot associates an initial proximal optimizing technique (pot), a side branch inflation and a final pot. a first clinical study (n=106 patients) confirmed these excellent mechanical results with serial oct analysis and demonstrated an excellent short term safety. since 2017, repot is recommended in europe in clinical practice. this large registry is dedicated to confirm the clinical benefits at long term after bifurcation revascularization with repot technique before a large randomise trial.


Eligibility criteria:
inclusion criteria: * discovery, during angiography, of a significant coronary lesion (by angiographic or functional assessment) including a bifurcation under a provisional stenting strategy. bifurcation have to be significant according to the operator and the coronary anatomy (but the side branch diameter have to be greater than 1.75mm) * stable lesion without high thrombus burden * patient agreement to study participation and ≥ 18 years exclusion criteria: * complex lesion or anatomy requiring revascularization strategy with more than one stent * contraindication to a double platelet anti-aggregation ≥ 6mois (recommended implantation of active stent) * unstable patient according to the operator (used of hemodynamic drug support, mechanical ventilation) * indication of cardiac surgery. * lesion culprit in st- or non st-elevation myocardial infarction \<12h. * high thrombus burden in angiography or endocoronary imaging (ivus, oct). * pregnancy, loose of legal right * other interventional study participation \<30 jours.
gastric barrier dysfunction of functional dyspepsia and therapeutic response to puyuanhewei detected by endomicroscopy

Conditions: Dyspepsia

Summary: functional dyspepsia might have impaired gastric mucosal dysfunction and puyuanhewei may be helpful to improve the symptoms of fd.

this study aimed to investigate the gastric mucosal dysfunction in functional dyspepsia (fd) and verify the efficacy of puyuanhewei for treating fd and assess the relationship between gastric microalterations and therapeutic response by endomicroscopy.

Eligibility criteria:
inclusion criteria: 1. consecutive outpatients aged 18 to 75 years old. 2. fd patients defined by the rome iii classification. 3. willing to choose pcle and no organic diseases. exclusion criteria: 1. severe liver, heart, or kidney diseases. 2. current or past evidence of uncontrolled diabetes mellitus, psychosomatic disorders, such as depressive and anxiety disorders, and drug or alcohol abuse. 3. pregnant or breastfeeding women. 4. inability to give informed consent. 5. use of nonsteroidal anti-inflammatory drugs, proton pump inhibitors, h2-receptor antagonists, antacids, prokinetics, or other injurious drugs (antibiotics, and steroids) in the prior two weeks.

Keywords: barrier dysfunction functional dyspepsia confocal laser endomicroscopic therapeutic response
use of polysomnography for non-invasive ventilation settings' optimization

Conditions: Obesity-Hypoventilation Syndrome (OHS)

Summary: the aim of this randomized controlled trial is comparing the improvement of diurnal paco2 in ohs patients after one month of niv treatment depending upon the tools used for adjusting settings. in one arm settings will be adjusted using only nocturnal oxygen sao2 and paco2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under niv.

initiation of niv treatment implies technical adjustments (choice of mask and ventilator), but also patient education by the nurses and medical staff. the settings are generally adjusted during the daytime in awake patients. the appropriateness of these settings is generally not optimal during sleep as many respiratory events (hypopnoea, apnea, leaks, desynchronization, and glottic closure) may occur under niv then reducing the effectiveness of treatment. these nocturnal abnormalities are routinely evaluated by measuring their consequences, i.e. oxygen desaturation and the level of paco2 after wake up. some teams are now proposing to better characterize what happens when using niv during sleep using polysomnography (psg). the precise characterization of residual events under treatment may allow optimizing ventilator settings.

Eligibility criteria:
inclusion criteria: * patient male or female, aged 20 to 75 years * patient with a ohs in stable condition, with a bmi\> 32 kg/m2 and a paco2\> 6 kpa in diurnal spontaneous breathing without other cause of alveolar hypoventilation * patient affiliated to a social security insurance * having given its written informed consent to participate to the study exclusion criteria: * patients with inherent chronic obstructive pulmonary disease (copd) with fev1 on forced vital capacity (fvc) ratio less than 70% * patients suffering from heart failure with periodic breathing * associated neurological diseases, evolving rapidly, leading to a dependency in daily activities * unbalanced psychiatric diseases * patients with a respiratory decompensation the month preceding the study * patients not autonomous in the use of the niv * pacemaker patients, constituting a contraindication to magnetic stimulation * sensitive subjects, in accordance with article l 1121-6 of the french public health code * patients with long term by steroids or other anti-inflammatory drugs
association of red blood cell transfusion, anemia, and necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis; Anemia; Red Blood Cell (RBC) Transfusion

Summary: necrotizing enterocolitis (nec) is a leading cause of mortality among preterm infants.the pathogenesis of nec remains unclear with conflicting data regarding the role of red blood cell (rbc) transfusion and anemia. a meta-analysis of retrospective studies demonstrated an association between exposure to rbc transfusion and nec(adjusted odds ratio, 2.0 \[95% confidence interval, 1.6-2.5\]). however, recent observational studies have found no association between rbc transfusion and nec or have found rbc transfusion to be protective.

improving understanding of the role of rbc transfusion and anemia in the development of nec is important. several studies characterizing the associations between transfusion, anemia, and nec were potentially limited by small sample size, study design. as such, researchers have underscored the need for prospective study in which each rbc exposure, episode of anemia, and outcome of nec can be systematically and consistently evaluated. this prospective study examined whether rbc transfusion and anemia were associated with the rate of nec. the primary objective was to test whether nec was increased in infants receiving rbc transfusion compared with non transfused infants. further, exposure to severe neonatal anemia was examined as an independent risk factor for nec.

Eligibility criteria:
inclusion criteria: * age between 1 min and 28 days * the level blood bilirubin reached the criteria of transfusion therapy exclusion criteria: * congenital abnormalities * receipt of transfusion before enrollment * parents' decision not to participate * infant not expected to survive beyond 7 days of life based on the assessment by the treating neonatologist

Keywords: necrotizing enterocolitis anemia red blood cell (rbc) transfusion
a study to evaluate retisert in the treatment of patients with the "wet" form of age-related macular degeneration

Conditions: Macular Degeneration

Summary: a study evaluating retisert in patients with age-related macular degeneration


Eligibility criteria:

Keywords: amd armd age-related macular degeneration subfoveal choroidal neovascularization cnv
autologous stem cell transplantation for patients with recurrent nasopharyngeal carcinoma

Conditions: Recurrent Nasopharynx Carcinoma

Summary: this is a pilot study to evaluate the response rates for patients undergoing high dose conditioning chemotherapy using etoposide, carboplatin and ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent nasopharyngeal cancer (npc) in children, adolescents, and young adults.

the use of high dose chemotherapy followed by autologous peripheral blood stem cell (pbsc) transplantation in recurrent nasopharyngeal carcinoma has shown promise when compared with standard chemotherapy. this study has been designed to evaluate response rates and toxicities associated with undergoing high dose conditioning with etoposide, carboplatin and ifosfamide followed by autologous stem cell transplantation support in the treatment of recurrent nasopharyngeal carcinoma in children, adolescents, and young adults.

Eligibility criteria:
inclusion criteria: * imaging and tissue diagnosis of recurrent or progressive nasopharyngeal carcinoma * documentation of previous treatment including conventional chemotherapy and/or radiation therapy as clinically appropriate * ages 2 to 30 years of age * negative serum pregnancy test if applicable * calculated creatinine clearance of greater than 60 ml/minute, serum creatinine of less than 12o micromoles/l, total bilirubin less than 2 mg/dl and aspartate aminotransferase (ast) must be less than twice the upper limit of normal exclusion criteria: * unsuitable candidate for autologous transplantation due to comorbidities or intractable psychosocial issues * pregnancy * breast-feeding women

Keywords: recurrent nasopharynx carcinoma